Trulicity, Eli Lilly's once-weekly GLP-1 shot, entered the US market in 2014
Trulicity arrived in 2014 as a once-weekly GLP-1 injection for type 2 diabetes; its label still lists a boxed warning and four pen strengths up to 4.5 mg [2].
Trulicity (dulaglutide) is a once-weekly GLP-1 receptor agonist injection from Eli Lilly. FDA-approved labeling for the product records an initial US approval in 2014, and the drug is licensed under biologics license application BLA 125469 [1][2].
The label carries two approved uses. One is improving blood sugar control in adults and in children 10 years and older with type 2 diabetes, as an addition to diet and exercise. The other is lowering the chance of major cardiovascular events — cardiovascular death, non-fatal heart attack or non-fatal stroke — in adults with type 2 diabetes who already have cardiovascular disease or several cardiovascular risk factors [2]. Weight loss does not appear among the approved uses [2].
Four single-dose pens are available, holding 0.75 mg, 1.5 mg, 3 mg or 4.5 mg of dulaglutide in 0.5 mL of solution [2]. Adults typically begin at 0.75 mg once a week, delivered under the skin. The label allows a step up to 1.5 mg after four weeks, then further increases of 1.5 mg at intervals of at least four weeks, to a ceiling of 4.5 mg weekly. Children 10 and older start at 0.75 mg weekly and top out at 1.5 mg weekly. Injections go into the belly, thigh or upper arm, at any hour, with or without food [2].
FDA's National Drug Code directory carries an entry for the 3 mg/0.5 mL pen, packaged as four syringes per carton, with a marketing start date of September 3, 2020, and a listing expiration of December 31, 2027 [1]. The directory does not list start dates for the 0.75 mg, 1.5 mg or 4.5 mg pens, and neither the directory nor the labeling says which strengths were on the market at the 2014 launch or how much the drug sold in its early years [1][2].
A boxed warning sits at the top of the prescribing information. Dulaglutide produced thyroid C-cell tumors in rats; the label says it is not known whether the drug does the same in people, because the relevance of the animal findings to humans has not been established [2]. People with a personal or family history of medullary thyroid carcinoma, or with Multiple Endocrine Neoplasia syndrome type 2, should not take the drug, nor should anyone who has had a serious allergic reaction to dulaglutide or another ingredient in the pen [2].
Nausea, diarrhea, vomiting, stomach pain and reduced appetite were the most frequent side effects, each reported in at least 5% of patients in trials [2]. The label also flags pancreatitis, low blood sugar when the drug is combined with insulin or a sulfonylurea-type medicine, serious allergic reactions, kidney injury from dehydration, severe stomach and bowel reactions (it is not advised for people with severe gastroparesis), diabetic retinopathy complications, gallbladder disease, and aspiration of stomach contents during general anesthesia or deep sedation [2]. Because dulaglutide slows the emptying of the stomach, it may delay how quickly oral medicines taken alongside it are absorbed [2].
Why it matters for patients
For anyone weighing GLP-1 options, Trulicity's label describes a schedule of one injection a week rather than a daily routine, and it can be given without regard to meals [2]. Doses are raised gradually, and the label ties that stepwise approach to lowering the chance of gastrointestinal side effects [2].
The boxed warning sets a hard boundary: a personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2, rules the drug out [2]. The label also notes that checking serum calcitonin levels or doing thyroid ultrasounds is of uncertain value for finding medullary thyroid carcinoma early in people taking the drug [2].
People who take GLP-1 medicines and then need elective surgery or a procedure have reported aspiration, according to the label, which asks patients to tell their health care providers about any planned surgery [2]. Trulicity is not approved for weight loss; its two approved uses are blood sugar control in type 2 diabetes and cardiovascular risk reduction in certain adults with that condition [2]. The current labeling does not present comparisons between Trulicity and other GLP-1 medicines [2].
What happens next
FDA's drug listing for Trulicity remains active through December 31, 2027 [1]. The two most recent major changes to the prescribing information are dated November 2024 and cover severe gastrointestinal adverse reactions and aspiration during general anesthesia or deep sedation [2]. No other upcoming label actions have been disclosed.
Sources
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